Modular transdermal compress device

ABSTRACT

A modular transdermal assembly configured to couple an external prosthetic device to a bone stump. The assembly includes a modular transdermal portion and a bone fixator. The modular transdermal portion includes an interface portion configured to couple with the external prosthetic device. The bone fixator is configured to be secured to the bone stump and couple with the modular transdermal portion to retain the modular transdermal portion relative to the bone stump.

FIELD

The present disclosure relates to a modular transdermal assemblyconfigured to couple an external prosthetic device to a bone stump.

BACKGROUND

This section provides background information related to the presentdisclosure and is not necessarily prior art.

Transdermal intraosseous devices can be used to couple externalprosthetic devices to a bone stump, such as subsequent to an amputation.While current transdermal intraosseous devices are suitable for theirintended use, they are subject to improvement. For example, currentdevices may not be well suited for accommodating multiple anatomies withvarying distances between a distal end of a bone stump and a distal skinarea opposite thereto. The present teachings provide numerousadvantages, such as, for example, a modular transdermal assemblyconfigured to couple an external prosthetic device to a bone stump thatcan accommodate a variety of different separation distances between thebone stump and a distal skin area opposite thereto.

SUMMARY

This section provides a general summary of the disclosure, and is not acomprehensive disclosure of its full scope or all of its features.

The present teachings provide for a modular transdermal assemblyconfigured to couple an external prosthetic device to a bone stump. Theassembly includes a modular transdermal portion and a bone fixator. Themodular transdermal portion includes an interface portion configured tocouple with the external prosthetic device. The bone fixator isconfigured to be secured to the bone stump and couple with the modulartransdermal portion to retain the modular transdermal portion relativeto the bone stump.

The present teachings further provide for a modular transdermal assemblykit for coupling an external prosthetic device to a bone stump. The kitincludes a plurality of modular transdermal portions of differentlengths, each including an interface portion configured to couple withthe external prosthetic device. The kit further includes at least onebone fixator configured to couple with the modular transdermal portionand retain the modular transdermal portion relative to the bone stump.

The present teachings also provide for a method for coupling an externalprosthetic device to bone. The method includes: implanting a bonefixator in a bone stump; selecting a modular transdermal portion from aplurality of modular transdermal portions of different lengths based ona distance between the bone stump and a distal portion of skin oppositeto the bone stump; coupling the selected modular transdermal portion tothe bone fixator; selecting a modular skin integration component from aplurality of modular skin integration components of differentgeometries; and coupling the modular skin integration component to theselected modular transdermal portion proximate to the distal portion ofskin.

Further areas of applicability will become apparent from the descriptionprovided herein. The description and specific examples in this summaryare intended for purposes of illustration only and are not intended tolimit the scope of the present disclosure.

DRAWINGS

The drawings described herein are for illustrative purposes only ofselected embodiments and not all possible implementations, and are notintended to limit the scope of the present disclosure.

FIG. 1 is a side view of a modular transdermal assembly according to thepresent teachings implanted in bone;

FIG. 2 is a cross-sectional view of FIG. 1 taken along line 2-2 of FIG.1;

FIG. 3 is a cross-sectional view of another modular transdermal assemblyaccording to the present teachings implanted in bone; and

FIG. 4 is a modular transdermal assembly kit according to the presentteachings.

Corresponding reference numerals indicate corresponding parts throughoutthe several views of the drawings.

DETAILED DESCRIPTION

Example embodiments will now be described more fully with reference tothe accompanying drawings.

With initial reference to FIG. 1, a modular transdermal implant assemblyaccording to the present teachings is generally illustrated at referencenumeral 10. The implant assembly 10 is illustrated as having beenimplanted into a bone stump 12. Extending about the bone stump 12 ismuscle tissue 14 and skin 16. A distal area of the skin 16 is at, andproximate to, reference numeral 18. Between the bone stump 12 and thedistal skin area 18 is a soft tissue envelope having a length X of theanatomy illustrated. The length X can vary depending on the patient'sanatomy. The bone stump 12 defines an intramedullary canal 20, whichextends to a distal end 22 of the bone stump 12.

The modular transdermal implant assembly 10 includes a bone fixator 30.The bone fixator 30 includes a bone anchor 32, which can be an anchorplug. The bone anchor 32 can be secured within the intramedullary canal20 in any suitable manner and with any suitable device, such as withbone pins 34.

Extending distally from the bone anchor 32 is an elongated rod 36. Theelongated rod 36 includes a small diameter portion 38 and a largediameter portion 40. The small diameter portion 38 is between the largediameter portion 40 and the bone anchor 32. Extending from the largediameter portion 40 is a bone collar 42. Extending distally from thebone collar 42 is a coupling portion or flange 44, which can include atapered coupling flange as illustrated. The bone collar 42 can have anysuitable size or shape, such as a disc-like shape as illustrated, whichhas a diameter larger than a diameter of the bone stump 12 at the distalend 22 thereof. The bone fixator 30 can be made of any suitablebiocompatible material, such as any suitable metal.

The modular transdermal implant assembly 10 further includes a modulartransdermal portion 50, which includes an elongated body or shaftportion 52. The elongated body portion 52 includes a proximal end 54 anda distal end 56 opposite thereto. Extending from the distal end 56 is atapered portion 60. Extending distally from the tapered portion 60 is anexternal adapter or connector 62. Therefore, the tapered portion 60 isbetween the elongated body portion 52 and the external adapter 62.

The external adapter 62 includes a prosthetic interface portion 64 at adistal end thereof. The prosthetic interface portion 64 can include anysuitable coupling portion or member, such as flattened surfaces 66 asillustrated. The prosthetic interface portion 64 is configured to coupleany suitable prosthetic device to the modular transdermal implantassembly 10, and at the distal skin area 18 of the patient. Theprosthetic device can be any suitable prosthetic device, such as aprosthetic leg, foot, arm, or hand.

The modular transdermal portion 50 can have any suitable lengthdepending on the patient's anatomy, such as depending on the length ofthe soft tissue envelope as measured based on the distance between thedistal end 22 of the bone stump 12 and the distal skin area 18. Themodular transdermal portion 50 can be included in a kit including aplurality of modular transdermal portions 50 of different lengths. Themodular transdermal portion 50 with the most appropriate length based onthe patient's anatomy can be selected and implanted as illustrated inFIG. 1, for example. Any portion of the modular transdermal portion 50can be provided with varying lengths to best fit the patient's anatomy.

For example, the elongated body portion 52 can have any suitable lengthbetween the proximal end 54 and the distal end 56 along the longitudinalaxis A. Thus, a plurality of modular transdermal portions 50 withvarying lengths of the elongated body portion 52 between the proximaland distal ends 54 and 56 along the longitudinal axis A can be provided,as illustrated at reference numbers 50 a-50 c in the exemplary kit 310of FIG. 4. The tapered portion 60 and/or the external adapter 62 caneach be provided with different lengths along the longitudinal axis A aswell. For example, transdermal portions 50 d-50 f of the kit 310 haveexternal adaptors 62 of different lengths. Thus kit 310 including aplurality of the modular transdermal portions 50 a-50 f can be providedin which the plurality of modular transdermal portions 50 included withthe kit have varying lengths along the longitudinal axis A at any one ormore of the elongated body portion 52, the tapered portion 60, and theexternal adapter 62.

The modular transdermal portion 50 can be coupled to the bone fixator 30in any suitable manner. For example, the modular transdermal portion 50can be coupled to the coupling flange 44 by arranging the modulartransdermal portion 50 such that the male coupling flange 44 extendsinto female coupling receptacle 58 of the elongated body portion 52 andis secured therein with a taper lock, such as a Morse taper lock. Thecoupling configuration can also be reversed, for example, such that thecoupling flange 44 extends from the proximal end 54 of the elongatedbody portion 52 into the coupling receptacle 58 included with the bonefixator 30.

The modular transdermal implant assembly 10 can further include anannular modular skin integration component 70. The modular skinintegration component 70 includes a skin ingrowth surface 72, which canbe made of any suitable material configured to permit skin growththerein in order to enhance fixation of the modular transdermal implantassembly 10 to surrounding skin 16, such as at the distal skin area 18.For example, the skin ingrowth surface 72 can be made of any suitableporous material, roughened material, etc.

With additional reference to FIG. 2, the modular skin integrationcomponent 70 is generally annular and defines a center bore 74. Thecenter bore 74 is generally tapered in the proximal to distal directionand includes a coupling member 80 seated therein. The coupling member 80includes a roughened outer surface 82 and an inner tapered surface 84opposite thereto. The roughened outer surface 82 engages the skiningrowth surface 72 in order to facilitate retention of the couplingmember 80 within the center bore 74. The inner tapered surface 84 can besolid, smooth, and tapered at an angle generally corresponding to thetapered portion 60 of the modular transdermal portion 50 such that uponpassing the modular skin integration component 70 over the externaladapter 62 and onto the tapered portion 60, the modular skin integrationcomponent 70 will be coupled to the tapered portion 60, such as with ataper lock.

The modular skin integration component 70, and particularly the skiningrowth surface 72 thereof, can have any suitable size or shape toaccommodate the patient's anatomy. The modular skin integrationcomponent 70 can be included in a kit having a plurality of modular skinintegration components 70, each with a different size and/or shape. Forexample, the kit 310 can include a plurality of modular skin integrationcomponents 70 a-701 having different shapes (such as tapered, rounded,or with straight edges 76), different lengths along the longitudinalaxis A, and different widths as measured extending outward and generallyperpendicular to the longitudinal axis A. The modular skin integrationcomponent 70 best suited for the patient's anatomy can be selected fromthe kit and coupled to the modular transdermal portion 50 at the taperedportion 60 as appropriate. This modularity provides a surgeon withmultiple ingrowth geometries to match or approximate the patient's softtissue envelope. This also allows the modular transdermal portion 50 tobe manufactured without the need to be sintered and/or without additivemanufacturing, both of which may have a lower fatigue strength comparedto wrought Ti-6-4 or Co—Cr, which the modular transdermal portion 50 canbe made of pursuant to the present teachings.

Another modular transdermal implant assembly according to the presentteachings is illustrated in FIG. 3 at reference numeral 110. Like themodular transdermal implant assembly 10, the assembly 110 is illustratedimplanted in bone stump 12 defining an intramedullary canal 20. Themodular transdermal implant assembly 110 includes a bone fixator 130including a bone anchor 132, which can be secured within intramedullarycanal 20 of the bone stump 12 in any suitable manner, such as with bonepins 134. The bone anchor 132 can be any suitable device for anchoringthe modular transdermal implant assembly 110 within the intramedullarycanal 120 of the bone stump 12, such as an anchor plug. Extending fromthe bone anchor 132 is a coupling portion in the form of a variablelength rod 136, the length of which can vary along longitudinal axis B.The kit 310 can include a plurality of rods 136 a-136 c having differentlengths along the longitudinal axis B. The variable length rod 136includes a threaded portion 138 at a distal end thereof. Connected tothe coupling portion 136 at the threaded portion 138 is a suitablefastener, such as a nut 140.

The modular transdermal implant assembly 110 further includes a modulartransdermal portion 150, which includes an elongated body portion orshaft 152 having a proximal end 154 and a distal end 156. At theproximal end 154 is a proximal flange 160 with an outer tapered surface162. The proximal flange 160 defines a bore 164 extending from theproximal end 154 to a receptacle 170 defined by the elongated bodyportion 152. Within the receptacle 170 are a plurality of compressionmembers 172.

The compression members 172 can be any suitable compliant member, suchas a plurality of Bellville washers, with neighboring ones of thecompression members 172 arranged opposite to one another. Each one ofthe compression members defines a center aperture through which thecoupling portion 136 extends. The fastener 140 is seated against adistal end of the most distal compression member 172. Thus with the boneanchor 132 secured within the intramedullary canal 20, the compressionmembers 172 provide the modular transdermal implant assembly 110 with acompliant fixator, which in turn provides a bone biasing force againstdistal end 22 of the bone stump 12. This bone biasing force can providea compressive load on the bone stump 12, which can result in reducedbone loss and can promote bone growth, for example. Compliance of thebone fixator 130 can exceed that of native bone, such that stressshielding does not occur. Any suitable compliant fixator can be used,including, but not limited to, the compliant fixators disclosed incommonly assigned U.S. Pat. Nos. 7,722,678; 7,141,043; 6,712,855;6,508,841; and 6,197,065, all of which are assigned to common AssigneeBiomet Manufacturing Corp. of Warsaw, Ind., and are incorporated hereinby reference.

The elongated body portion 152 can be provided with any suitable length,depending on the patient's anatomy. For example, the kit 301 can includea plurality of the elongated body portions 152 a-152 c having differentlengths along the longitudinal axis B, which can be selected toaccommodate the patient's anatomy, such as the distance X between thedistal end 22 of the bone stump 12 and the distal skin area 18 of thepatient's soft tissue envelope. Furthermore, the compression members 172can be stacked at any suitable height within the receptacle 170 to varythe distance between the bone anchor 132 and the elongated body portion152 in view of the length of the bone stump 12. This may be advantageousif a secondary or revision “tightening” of the modular transdermalimplant assembly 110 is appropriate, such as in view of degradation(i.e., shortening) of the bone stump 12.

The elongated body portion 152 further includes, at outer surfacesthereof, a proximal tapered surface 174 and a distal tapered surface176. Coupled to the distal tapered surface 176 is a modular transdermaladaptor or connector 180. The transdermal adapter 180 includes aproximal end 182 and a distal end 184 opposite thereto. The transdermaladaptor 180 can be selected from a plurality of transdermal adaptors 180a-180 c of kit 310 having different lengths along the longitudinal axisB to best fit the patient's soft tissue envelope, such as the distance Xbetween the distal end 22 of the bone stump 12 and the distal skin area18 of the patient's soft tissue envelope. At the proximal end 182, thetransdermal adapter 180 defines a receptacle 186, which includes aninternal tapered surface 188 extending distally from the proximal end182. At the distal end 184 is a prosthetic interface portion 190, whichcan be any suitable portion or device configured to retain any suitableprosthetic to the transdermal adapter 180, such as a prosthetic leg,foot, arm, or hand. As illustrated, the prosthetic interface portion 190is threaded to receive threads of the prosthetic device.

The elongated body portion 152 is received within the transdermaladapter 180 such that the distal tapered surface 176 of the elongatedbody portion 152 mates with the internal tapered surface 188 of thetransdermal adapter 180 to secure the elongated body portion 152 and thetransdermal adapter 180 together, such as with a taper lock. Theelongated body portion 152 and the transdermal adapter 180 can becoupled together in any other suitable manner as well.

The transdermal adapter 180 further includes an intermediate outertapered surface 192 between the proximal end 182 and the distal end 184.The intermediate outer tapered surface 192 is sized and shaped tocooperate with the inner tapered surface 84 of the modular skinintegration component 70 in order to couple the modular skin integrationcomponent 70 to the transdermal adapter 180 in any suitable manner, suchas with a taper lock. When the modular skin integration component 70 isincluded in the kit 302 of a plurality of modular skin integrationcomponents 70 of different sizes and shapes, such as components 70 a-70i, any one of the modular skin integration components 70 of the kit maybe coupled to the transdermal adapter 180 to accommodate the patient'sanatomy.

The modular transdermal implant assembly 110 further includes a modularbone integration component 210 including bone ingrowth material 212. Thebone ingrowth material 212 can be any suitable material configured topermit growth of bone therein to enhance fixation of the modular boneintegration component 210 to the bone stump 12. For example, the boneingrowth material 212 can be made of materials that are porous,roughened, etc. The modular bone integration component 210 defines aninner tapered surface 214 to which a coupling member 216 is mounted. Thecoupling member 216 can be made of any suitable material, such as ametallic material, and includes a tapered surface 218 configured to matewith the proximal tapered surface 174 of the elongated body portion 152in order to couple the modular bone integration component 210 to theelongated body portion 152. The tapered surface 218 can be smooth andsolid. A roughened surface 220 can be included opposite to the taperedsurface 218 to secure the coupling member 216 to the modular boneintegration component 210.

The modular bone integration component 210 can have any suitable size orshape to accommodate the patient's anatomy, such as the anatomy at thedistal end 22 of the bone stump 12. The kit 310 may include a pluralityof modular bone integration components 210 a-1, each having differentsizes and/or shapes, which can be selected for implantation based on thepatient's anatomy. The modular bone integration components 210 a-210 ican have different shapes (such as tapered, rounded, or with straightedges 222), different lengths along the longitudinal axis A, anddifferent widths as measured extending outward and generallyperpendicular to the longitudinal axis A.

The present teachings further provide for a method for coupling theexternal prosthetic device to the bone stump 12. The method can includeimplanting the bone fixator 30 or 130 in the bone stump 12. The modulartransdermal portion 50 or 150 is selected from a plurality of modulartransdermal portions of different lengths, such as 50 a-50 f orelongated body portions 152 a-152 c, based on a distance between thebone stump 12 and the distal portion of skin opposite 18 to the bonestump 12. The selected modular transdermal portion 50 a-50 f or bodyportion 152 a-152 c is coupled to the bone fixator 30 or 130. Themodular skin integration component 70 is selected from a plurality ofmodular skin integration components 70 a-70 i of different geometries.The modular skin integration component 70 a-70 i is then coupled to theselected modular transdermal portion 50 or 150 proximate to the distalportion 18 of skin 16, such as with a taper lock. A modular boneintegration component 210 a-2101 can be selected from a plurality ofdifferent bone integration components 210 a-210 i of different shapesand sizes as described above, and can be coupled to the selected modulartransdermal portion 50 or 150 proximate to the bone stump 12, such aswith a taper lock.

The foregoing description of the embodiments has been provided forpurposes of illustration and description. It is not intended to beexhaustive or to limit the disclosure. Individual elements or featuresof a particular embodiment are generally not limited to that particularembodiment, but, where applicable, are interchangeable and can be usedin a selected embodiment, even if not specifically shown or described.The same may also be varied in many ways. Such variations are not to beregarded as a departure from the disclosure, and all such modificationsare intended to be included within the scope of the disclosure.

1.-20. (canceled)
 21. A modular transdermal assembly comprising: amodular transdermal portion comprising: a proximal end; a distal endopposite the proximal end, the distal end couplable to an externalprosthetic device; and an outer tapered surface between the proximal endand the distal end; a bone fixator comprising: a first end securable toa bone stump; and a second end opposite the first end, the second endcoupleable to the proximal end of the modular transdermal portion; and amodular skin integration component selectable from a plurality ofmodular skin integration components each having a different shape, themodular skin integration component coupleable to the modular transdermalportion.
 22. The modular transdermal assembly of claim 21, the modularskin integration component further comprising: a center bore including atapered surface to interface with the outer tapered surface of themodular transdermal portion.
 23. The modular transdermal assembly ofclaim 22, further comprising: a coupling member configured to seatbetween the modular transdermal portion and the modular skin integrationcomponent.
 24. The modular transdermal assembly of claim 23, wherein thecoupling member includes a roughened outer surface configured to engagethe modular skin integration component, and further includes an innertapered surface sized and shaped to interface with the outer taperedsurface of the modular transdermal portion.
 25. The modular transdermalassembly of claim 22, wherein the center bore is tapered in the proximalto distal direction.
 26. The modular transdermal assembly of claim 21,wherein the modular skin integration component is selectable to have adesired shape based on a patient's anatomy.
 27. The modular transdermalassembly of claim 21, the modular skin integration component furthercomprising: a skin ingrowth surface disposed around at least a portionof a periphery of the modular skin integration component, the skiningrowth surface configured to receive skin ingrowth therein.
 28. Amodular transdermal assembly comprising: a modular transdermal portioncomprising: a proximal end; a distal end couplable to an externalprosthetic device; and an outer tapered surface between the proximal endand the distal end; a bone fixator comprising: a first end securable toa bone stump; and a second end coupleable to the proximal end of themodular transdermal portion; and a modular skin integration componentcoupleable to the modular transdermal portion.
 29. The modulartransdermal assembly of claim 28, wherein the modular skin integrationcomponent is selectable from a plurality of modular skin integrationcomponents each having a different geometry.
 30. The modular transdermalassembly of claim 28, the modular transdermal portion furthercomprising: an interface portion located proximate the distal end andcoupleable to the external prosthetic device, the outer tapered surfaceof the modular transdermal portion facing toward the distal end.
 31. Themodular transdermal assembly of claim 28, further comprising: a couplingmember configured to seat between the modular transdermal portion andthe modular skin integration component.
 32. The modular transdermalassembly of claim 31, the coupling member further comprising: an innertapered surface sized and shaped to interface with the outer taperedsurface of the modular transdermal portion.
 33. The modular transdermalassembly of claim 31, further comprising: a skin ingrowth surfacedisposed around at least a portion of a periphery of the skinintegration component, the skin ingrowth surface configured to receiveskin ingrowth therein.
 34. The modular transdermal assembly of claim 33,wherein the skin ingrowth surface is configured permit skin growththerein in order to enhance fixation of the modular transdermal implantassembly to surrounding skin of the patient.
 35. The modular transdermalassembly of claim 33, wherein the modular skin integration component isselectable from a plurality of modular skin integration components eachhaving a different geometry, and wherein the skin ingrowth surface ofeach of the plurality of modular skin integration components comprises asuitable size or shape to accommodate the patient's anatomy.
 36. Themodular transdermal assembly of claim 32, wherein the inner taperedsurface of the coupling member is configured to face the proximal end ofthe modular transdermal portion, and wherein the modular skinintegration component restrains distal movement of the modulartransdermal portion.
 37. The modular transdermal assembly of claim 31,the modular skin integration component further comprising: a center boreincluding a tapered surface to interface with the outer tapered surface.38. The modular transdermal assembly of claim 37, wherein the couplingmember includes a roughened outer surface engageable with the skiningrowth surface to facilitate retention of the coupling member withinthe center bore.